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FDA 510(k)

mJOULE System and Accessories

K-Number: K213350 · 2022-04-15

ApplicantSciton, Inc
Decision Date2022-04-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

mJOULE System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Sciton, Inc. It received FDA 510(k) clearance on 2022-04-15 under 510(k) number K213350. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the mJOULE System and Accessories?

mJOULE System and Accessories is a medical device that received FDA 510(k) clearance on 2022-04-15. The listed applicant is Sciton, Inc. The 510(k) number is K213350.

When did mJOULE System and Accessories receive FDA 510(k) clearance?

mJOULE System and Accessories received FDA 510(k) clearance on 2022-04-15, under 510(k) number K213350.

Who is the listed applicant for mJOULE System and Accessories?

The FDA 510(k) record lists Sciton, Inc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mJOULE System and Accessories?

The FDA product code for mJOULE System and Accessories is GEX. This falls under the Gastroenterology category.

Other records listing Sciton, Inc as applicant

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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